Many devices are a modified version of the “clean slate” device that was placed on the market decades ago and devices frequently change hands from one company to another and...
This presentation will provide a snapshot of a shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of...
This presentation was delivered at the CPhI tradeshow in Madrid, Spain on June 14, 2018. Passports, ID cards, fingerprints, metal detectors, iris recognition, camera’s… we are trying to reveal the...
Nelson Labs Europe’s capabilities are complementary and additive to Nelson Labs’ existing testing portfolio and, in combination, makes Nelson Labs one of the premiere global E&L laboratory testing platforms for...
The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate...
